Metabolic Abnormalities - HIV Infected and Uninfected Males

This study has been completed.

Sponsor:

University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT00260936

First Posted: December 2, 2005

Last Update Posted: March 1, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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HIV-infected and -uninfected males, ages 12 to 24 years, of Tanner Stage 4 or 5

HIV-positive, has never been on ART

HIV-positive, has never been on ART

HIV-positive, non PI containing NNRTI-based regimen

HIV-positive, currently on a non-PI-containing NNRTI-based regimen for at least 12 weeks. Must never have received a total of more than 6 months of PI-containing regimen, and at least one year must have passed since receipt of last PI-containing regimen

HIV-positive, non-NNRTI-containing PI-based regimen

HIV-positive, currently on a non-NNRTI-containing PI-based regimen for at least 12 weeks. Must never have received a total of more than 6 months of NNRTI-containing regimen, and at least one year must have passed since receipt of last NNRTI-containing regimen.

Detailed Description:

The study involves a one-time collection of health and medical history data, blood and urine specimens, and physical assessments. This study will elucidate the need for a further in-depth study to understand the pathophysiological effects of protease inhibitor (PI)-based and non-nucleoside analogue reverse transcriptase inhibitor (NNRTI)-based therapies in young men.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

12 Years to 24 Years (Child, Adult)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

Approximately 250 subjects will be enrolled in the study. The number of subjects enrolled in each study group will be as follows: 50 HIV-negative subjects; 100 HIV-positive subjects who are antiretroviral therapy (ART) naïve; and two groups of up to 50 HIV-positive subjects each, one on an NNRTI-based regimen and the other on a PI-based regimen.

Criteria

Inclusion Criteria:

Males age 12 years and 0 days through 24 years and 364 days.

Tanner stage 4 or 5.

Accessible medical history and medications history.

Willingness to fast and complete all clinical evaluations and specimen collection.

Willingness and ability to give informed consent or assent with parental/legal guardian permission, where required.

Group 1: HIV-Negative Control Subject Specific Inclusion Criteria

All subjects for Group 1 will be tested for HIV-1 to confirm negativity unless they have a documented negative antibody test within the last three months of study entry.

HIV-1 infection as documented by a positive result on any of the following licensed tests at any time: any antibody test confirmed by Western blot, HIV culture, plasma HIV-1 RNA PCR >1,000 copies/ml or HIV-1 DNA PCR.

Group 3: Currently on a NNRTI, non-PI containing regimen for three or more months, must never have received a total of more than six months of PI-containing regimen and at least one year must have passed since receipt of last PI-containing regimen.

Group 4: Currently on a PI, non-NNRTI containing regimen for three or more months, must never have received a total of more than six months of NNRTI-containing regimen and at least one year must have passed since receipt of last NNRTI-containing regimen.

Exclusion Criteria:

Transgender male to female (MTF) or female to male (FTM) youth

Refusal to fast for the 8 hours before collection of laboratory specimen requiring fasting.